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01 1Fermion Oy
02 1Formosa Laboratories
03 1Hangzhou Longshine Bio-Tech
04 1Hetero Drugs
05 1MSN Laboratories
06 1Shandong Haohong Biotechnology Co.,ltd
07 1Sun-shine Chem
08 1Tecoland Corporation
09 1Viatris
01 3China
02 1Finland
03 2India
04 1Taiwan
05 2U.S.A
01 2Active
02 7Blank
01 9Blank
01 9Blank
01 1WC-0349
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34419
Submission : 2019-12-26
Status : Active
Type : II
NDC Package Code : 66499-0064
Start Marketing Date : 2018-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35585
Submission : 2021-01-30
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0109
Start Marketing Date : 2021-01-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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